QA Data Reviewer

Requirements:

• Permanent Canadian residency with a work permit and/or Canadian citizenship; must be living in Canada, preferably in the Toronto area.
• Minimum B.Sc. in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or a similar applied scientific discipline.
• At least 3 years of experience reviewing laboratory data in a pharmaceutical QA environment.
• Sound knowledge of pharmaceutical analytical laboratory methods and instrumentation, including wet chemistry and instruments such as LC/MS/MS, HPLC, GC-Headspace, GC/MS, ICP-MS, and dissolution equipment.
• Proficiency in method development and validation, investigational studies, method transfer, stability studies, and preparing and executing reports and protocols.
• Familiarity with USP, BP, EP, and JP methods and specifications.
• In-depth knowledge of cGMP/GMP, GDP, GxP, FDA CFR 211, ICH, and ALCOLA+ regulations and quality-system guidelines.
• Experience creating and reviewing SOPs, OOS reports, and change-control documentation.
• Strong troubleshooting, problem-solving, organizational, communication, and decision-making skills; able to work independently, manage multiple tasks, and meet timelines in a fast-paced environment.
• Team-oriented, punctual, detail-focused, and proficient with Microsoft Office, including Excel, Word, and PowerPoint.

Responsibilities:

• Plan and deliver QA activities, overseeing and evaluating the technical work of the department.
• Ensure company processes, procedures, and policies comply with applicable Health Canada, US FDA, WHO, European GMP, GxP, ICH, MHRA, and ALCOLA+ requirements.
• Review QC and R&D data, reports, protocols, analytical results, and laboratory documentation for technical quality and compliance.
• Identify analytical testing deviations, OOS, and OOT results; issue review observations and work with scientific staff to support data integrity.
• Track QC review metrics and identify opportunities to improve processes.
• Guide and educate laboratory staff on GxP best practices.
• Develop GMP documentation, including SOPs, forms, protocols, and reports, and ensure laboratory records meet GDP requirements.
• Coordinate laboratory investigations from initiation through closure; lead or participate in deviation, OOS, OOT, change-control, CAPA, and customer-complaint investigations.
• Prepare and approve analytical test results, Certificates of Analysis, and reports.
• Manage and deliver the company training program.
• Coordinate and participate in internal, client, supplier, and regulatory audits and inspections, including inspection-readiness activities.
• Work with cross-functional stakeholders to follow up on quality issues.
• Review and ensure equipment and instrument qualification, calibration, repair, and maintenance records are current and archived.
• Maintain quality and laboratory reports, records, and analyst notebooks in good order.

Technologies:

• Excel
• Support

More

We are Shields Pharma Inc., a Health Canada-approved GMP organization in Markham, Ontario. We provide laboratory R&D and QC testing, as well as production and formulation of psychedelic therapeutics for certain mental health disorders. We are seeking a QA Analytical Data Reviewer for our growing team. The role reports to the Head of Quality & Compliance and supports quality oversight of internal and external GxP documentation. We are an equal opportunity employer committed to diversity and inclusion. Our people are central to our work, and our core values include safety, integrity, and accountability, alongside continuous training and skill development. We welcome applications from qualified candidates; only selected applicants will be contacted for an interview.

last updated 43 week of 2026